docetaxel

Generic: docetaxel

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name docetaxel
Generic Name docetaxel
Labeler gland pharma limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

docetaxel anhydrous 10 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-399
Product ID 68083-399_98672249-02db-4f71-9b49-a76e3ef56a21
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213510
Listing Expiration 2026-12-31
Marketing Start 2021-07-01

Pharmacologic Class

Established (EPC)
microtubule inhibitor [epc]
Physiologic Effect
microtubule inhibition [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083399
Hyphenated Format 68083-399

Supplemental Identifiers

RxCUI
1093280 1860619
UPC
0368083401016 0368083400019 0368083399016
UNII
699121PHCA
NUI
N0000175085 N0000175592

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name docetaxel (source: ndc)
Generic Name docetaxel (source: ndc)
Application Number ANDA213510 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-399-01) / 2 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

68083-399-01 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-399-01) / 2 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

docetaxel anhydrous (10 mg/mL)

Linked Drug Pages (1)

Docetaxel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "98672249-02db-4f71-9b49-a76e3ef56a21", "openfda": {"nui": ["N0000175085", "N0000175592"], "upc": ["0368083401016", "0368083400019", "0368083399016"], "unii": ["699121PHCA"], "rxcui": ["1093280", "1860619"], "spl_set_id": ["14cbd8f6-e11b-4d64-aa4c-e70a2ecbf975"], "pharm_class_pe": ["Microtubule Inhibition [PE]"], "pharm_class_epc": ["Microtubule Inhibitor [EPC]"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (68083-399-01)  / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "68083-399-01", "marketing_start_date": "20210701"}], "brand_name": "Docetaxel", "product_id": "68083-399_98672249-02db-4f71-9b49-a76e3ef56a21", "dosage_form": "INJECTION", "pharm_class": ["Microtubule Inhibition [PE]", "Microtubule Inhibitor [EPC]"], "product_ndc": "68083-399", "generic_name": "Docetaxel", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Docetaxel", "active_ingredients": [{"name": "DOCETAXEL ANHYDROUS", "strength": "10 mg/mL"}], "application_number": "ANDA213510", "marketing_category": "ANDA", "marketing_start_date": "20210701", "listing_expiration_date": "20261231"}